跳至主要内容
临床试验/NCT01565980
NCT01565980
已完成
不适用

A Mindfulness Intervention for Symptom Management in Lung Cancer

Michigan State University3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年3月最近更新:
适应症Lung Cancer

概览

阶段
不适用
状态
已完成
入组人数
40
试验地点
3
主要终点
M.D. Anderson Symptom Inventory (MDASI)

概览

简要总结

Managing psychological and physical symptoms to improve quality of life in patients with lung cancer are a major public health concern. Mindfulness-based therapies are showing promise in modifying psychological distress and improving quality of life in some cancer groups, but little testing has included lung cancer samples. Mindfulness-based therapies integrate meditation, breathing, and gentle yoga practices to promote an attitude of nonjudgmental acceptance and awareness of bodily states. Such strategies may promote well being, self-regulation, and symptom management. The study purpose was to test the acceptability, feasibility, and symptom / health-related quality of life (HRQOL) outcomes of a home-based mindfulness intervention for individuals with advanced lung cancer during non-curative treatment (radiation and/or chemotherapy). Acceptability and feasibility were measured via patient consent and retention rates, therapy expectancy, study adherence, attrition reasons, and quality assurance indicators. Efficacy was determined via symptom and HRQOL (health perceptions, physical and emotional function) outcomes. 40 patients undergoing treatment of non-small cell lung cancer were randomized to receive either six weekly mindfulness sessions (N=20) or an attention control condition (N=20). Outcome data was obtained at baseline (Time 1), post-intervention (Time 2, week 8), and four weeks after completion (Time 3, week 11). In addition, both groups received weekly symptom assessment interviews. The hypothesis was that the mindfulness group would report better symptom management and HRQOL (lower worry, dyspnea, insomnia, depression; higher physical and social function; more positive health perceptions) than the attention control group at the protocol end and that these differences will be sustained at Time 3.

详细描述

The final sample (n = 32) included 16 patients in the intervention and 16 in the attention control group (study attrition (n = 8, 20%).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able to understand and speak English
  • at least 21 years old
  • active treatment for a diagnosis of non-small cell lung cancer
  • Karnofsky score \> 80
  • have a telephone by which they can be reached

排除标准

  • current substance abuse other than tobacco
  • active treatment for psychiatric disorders excluding depression, and/or use of antipsychotic medications that would impede study participation.
  • cognitive impairment
  • active participation in mindfulness-based classes, guided imagery, yoga, or relaxation therapy courses
  • diagnosis of small cell lung cancer

结局指标

主要结局

M.D. Anderson Symptom Inventory (MDASI)

时间窗: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.

Symptom Severity and interference were measured with the M.D. Anderson Symptom Inventory (MDASI) . The MDASI is a multisymptom patient-reported outcome measure. The MDASI has 13 core items include symptoms found to have the highest frequency and/or severity in patients with various cancers and treatment types (pain, fatigue, nausea, vomiting, disturbed sleep, distress, shortness of breath, memory difficulties, lack of appetite, drowsiness, dry mouth, sadness,numbness and tingling. Patients rate the severity of each symptom "at its worst" using 0-10 numerical rating scales with 0 = "not present" and 10 = "as bad as you can imagine." The measure includes 5 symptom interference items which ask how much all symptoms, interfere with domains (walking, work, general activity, mood, relations with others, enjoyment of life) also rated on a 0-10 scale (0 = "did not interfere"; 10 = "interfered completely"). The 13 severity (range 0 - 130) and 5 interference items (range 0 - 50) are summed.

SF-36

时间窗: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.

Health-related Quality of Life (HRQOL) Indices (Physical/Emotional Function, Role Function, Pain, General Health, Vitality, Mental/Physical Health)HRQOL(SF-36) calculated using Quality Metric, Inc. an algorithm producing normal scores (1-100 range). With normed scoring, general population has mean=50, SD=10. For the minimum and maximum values in each of the scale ranges provided, higher values represent a better outcome.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rebecca Lehto

PhD, RN, Assistant Professor

Michigan State University

研究点 (3)

Loading locations...

相似试验